Registration Dossier
Registration Dossier
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EC number: 244-838-7 | CAS number: 22204-53-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Species:
- rabbit
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Naproxen given orally up to 60 mg/kg/day to pregnant rabbits did not affect fertility, gestation or number of live fetuses.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
- Species:
- rat
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Naproxen given orally to pregnant rats up to 20 mg/kg/day did not result in adverse effects in viability of pups, lactation index, sex ratio, or weight gain of offspring; however, slight increases in gestation length and significant increases in stillbirths was seen at > 10 mg/kg. Fetal deaths seen in naproxen-treated rats were apparently related to dystocia rather than to a direct toxic effect of the drug, as similar effects were observed with other commonly used nonsteroidal anti-infiammatory agents in the rat.
Justification for classification or non-classification
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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